Biomedical Engineering Reference
In-Depth Information
abc Pharmaceutical comPany
ANNEXURE II
LEVEL 3
INSPECTION OF PHYSICAL ATTRIBUTES
TABLET (CORE)
Product name:
Batch size:
Code No.:
Sample size:
Batch No.:
Description:
DEFECTS
BATCH SIZE
SAMPLE
ACCEPTANCE
CRITICAL
SIZE
AQL
0.0%
Foreign product/odor
ACC.
REJ.
Gross foreign matter
35,001 to 150,000
125
0
1
Thick & thin tablet
125
0
1
Other defects
150,001 to 500,000
200
0
1
200
0
1
Other defects
500,001 & over
315
0
1
Total critical
defects
315
0
1
Sample size
MAJOR
AQL
1%
Capping
ACC.
REJ.
Broken
35,001 to 150,000
125
2
5
Dirty (specks/particles)
125
6
7
Picking (large)
150,001 to 500,000
200
3
7
Color variation (major)
200
8
9
Sticking
500,001 & over
315
5
9
Other defects
315
12
13
Total critical
defects
Sample size
MINOR
AQL
2.5%
Chipping
ACC.
REJ.
Picking (small)
35,001 to 150,000
125
5
9
Small specks
125
12
13
Pitting (porous surface)
150,001 to 500,000
200
7
11
Sticking (small)
200
18
19
Other defects
500,001 & over
315
11
16
Total critical
defects
315
26
27
Sample size
Disposition:
Conforms
Doesn't conform
Remarks:
Analyst
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